| CTRI Number |
CTRI/2024/11/076863 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [implementation trial] |
| Study Design |
Other |
|
Public Title of Study
|
Nutrition Education for Community Health Workers: Supporting Pregnant Women |
|
Scientific Title of Study
|
Capacity building of Community Health Officers (CHOs), Primary Health Care Officers (PHCOs), and Accredited Social Health Activists (ASHAs) on prenatal nutrition and dietary diversity through a nutrition educational module: An intervention study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMRUTHA M S |
| Designation |
Assistant Professor |
| Affiliation |
MAHE |
| Address |
Department of Clinical Nutrition and Dietetics,MCHP,MAHE,MANIPAL-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8762067994 |
| Fax |
|
| Email |
amrutha.ms@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shashikala K Bhat |
| Designation |
Professor and Head |
| Affiliation |
MAHE |
| Address |
Dept. of Obstetrics and Gynecology
Dr.TMA Pai Hospital
MMMC, MAHE, Manipal
Udupi
KARNATAKA
576101
India |
| Phone |
9611362119 |
| Fax |
|
| Email |
shashikala.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
AMRUTHA M S |
| Designation |
Assistant Professor |
| Affiliation |
MAHE |
| Address |
Department of Clinical Nutrition and Dietetics,MCHP,MAHE,MANIPAL-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8762067994 |
| Fax |
|
| Email |
amrutha.ms@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal college of health profession,Manipal Academy of higher education,Manipal,India-576104 |
|
|
Primary Sponsor
|
| Name |
AMRUTHA M S |
| Address |
Department of Clinical Nutrition and Dietetics, MCHP,MAHE,MANIPAL-576104 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashikala K Bhat |
Dr. TMA Pai Hospital – Udupi and District Health and Family Welfare(DHO) |
Department of Obstetrics and Gynecology ,Dr. TMA Pai Hospital – Udupi and District Health and Family Welfare(DHO),Udupi
Udupi
KARNATAKA |
9611362119
shashikala.bhat@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women visiting Government and Private Hospitals in and around Udupi taluk
CHO PHCO AND ASHA of Udupi taluk |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
capacity building through nutrition educational module. |
Objective 1: KAP and Focus group discussions (FGDs)
After obtaining participant consent, expert validated semi-structured KAP questionnaire will be administered to 20% of known population of CHOs (32), PHCOs (43), and ASHAs (157) in Udupi taluk. Each participant will complete the questionnaire in a 45-minute session at the DHO office. Additionally, focus group discussions (FGDs) will be conducted with 8 CHOs, 8 PHCOs, and 8 ASHAs. These discussions, conducted in the local language and lasting 45 minutes each, will be recorded, transcribed, and translated into English.
Objective 2: Nutrition and dietary diversity awareness of pregnant women.
Pregnant women visiting Obstetrics and gynaecology department of Government and Private Hospitals in and around Udupi taluk will be informed about the study and asked for their consent. Semi-structured interviewer administered will be used to gather data on their awareness of prenatal nutrition and dietary diversity. The Minimum Dietary Diversity for Women (MDD-W) tool will be used to record and categorize food intake from the past 24 hours. Overall session will last for 45 minutes.
Intervention programme development
Objective 3: Develop an education module
Using the data collected from KAP questionnaires and FGDs, the educational module will be customized based on the KAP scores received from ASHAs, CHOs, and PHCOs to cover essential topics such as the meaning of a healthy diet, consuming a variety of foods, sources of main food groups and micronutrients, optimizing local food for nutrition, hazards of maternal malnutrition, essential supplements during pregnancy, avoiding harmful substances, gestational weight gain, managing common discomforts related to nutrition during pregnancy, communication strategies, home visits and outreach, teamwork, time management, and follow-up.
Training session
A validated modified KAP semi structured questionnaire (pre-training) will be provided on the first day of training to establish a baseline and evaluate KAP improvement post-training. Training sessions will be organized once a month in two batches: Batch 1 will attend morning sessions, and Batch 2 will attend afternoon sessions, each lasting three hours, over four months. The training will include PowerPoint presentations, printed materials, and interactive discussions, supplemented with self-reading flip charts in the native language.
Post Assessment
Objective 4: Post KAP
Following the training, same modified KAP (post training) semi-structured questionnaire will be administered at one, three, and six months to measure changes in knowledge, attitudes, and practices. Each follow-up session will last 45 minutes and be held at the DHO office. The data collected will be analyzed to evaluate the long-term impact of the training program on participants KAP related to prenatal nutrition.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
a) Inclusion and exclusion criteria:
Phase 1- KAP
Inclusion criteria:
1. CHOs, PHCOs and ASHAs who are providing services in Udupi taluk.
2. CHOs, PHCOs and ASHAs giving consent for study participation and are willing to participate in the
training programme.
Phase 2-Focus group discussion (FGD)
Inclusion criteria:
1. CHOs, PHCOs and ASHAs who active in their roles in providing services in Udupi taluk, for more ≥
5 years.
2. CHOs, PHCOs and ASHAs who provide consent for study participation and agree to have their
conversations recorded during the focus group discussion (FGD).
1. All Pregnant women visiting Obstetrics and gynaecology department of Government and Private Hospitals in and around Udupi taluk..
2. Primigravida.
3. Pregnant women giving consent for study participation.
Objective 3- To develop an education module on prenatal nutrition and dietary diversity for CHOs, PHCOs and ASHAs as part of a capacity building training program.
Objective 4- To assess the effectiveness of capacity building training program for CHOs, PHCOs and ASHAs on prenatal nutrition and dietary diversity.
Inclusion criteria:
1. CHOs, PHCOs and ASHAs who are providing services in Udupi taluk.
2. CHOs, PHCOs and ASHAs giving consent for study participation and are willing to participate in the training programme. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Develop a comprehensive prenatal nutrition education module and build capacity for CHOs, PHCOs, and ASHAs to enhance quality counseling and address malnutrition by emphasizing dietary diversity and evidence-based practices. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="266"
Sample Size from India="266"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There is a critical need to evaluate and enhance the training of Community Health Officers (CHOs), Primary Health Centre Officers (PHCOs), and Accredited Social Health Activists (ASHAs) in India, as they play a pivotal role in maternal and child health at the grassroots level. Despite existing programs, there is limited data on the effectiveness and coverage of their training in areas such as dietary diversity, weight management, and tailored nutritional interventions. Addressing this gap is essential for improving the nutritional knowledge and support provided to pregnant women, particularly in rural and remote areas, thereby positively impacting maternal and child health outcomes. |